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Last Updated: May 18, 2024

Claims for Patent: 11,229,647

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Summary for Patent: 11,229,647

Title:	Methods for treating cholestasis
Abstract:	Provided herein are methods for treating cholestasis in a subject having a liver disease. The method includes administering to the subject an Apical Sodium-dependent Bile Acid Transporter (ASBTI). More specifically, the present invention relates to methods for treating cholestasis in a subject where the method includes administering an ASBTI to a subject at a dose of at least 10 .mu.g/kg/day.
Inventor(s):	Jaecklin; Thomas (Delemont, CH), Dorenbaum; Alejandro (Mill Valley, CA)
Assignee:	MIRUM PHARMACEUTICALS, INC. (Foster City, CA)
Application Number:	16/994,368
Patent Claims:	1. A method for treating Alagille Syndrome (ALGS) in a pediatric subject in need of such treatment comprising administering to the subject ##STR00064## (maralixibat chloride), wherein maralixibat chloride is administered in an amount of from about 400 .mu.g/kg/day to about 800 .mu.g/kg/day. 2. The method of claim 1, wherein maralixibat chloride is administered once daily (QD). 3. The method of claim 1, wherein maralixibat chloride is administered twice daily (BID). 4. The method of claim 1, wherein maralixibat chloride is administered for at least 18 weeks. 5. The method of claim 1, wherein maralixibat chloride is administered for at least 2 years. 6. The method of claim 1, wherein maralixibat chloride is administered for at least 3 years. 7. The method of claim 1, wherein the subject exhibits below normal height or weight prior to the administration of maralixibat chloride. 8. The method of claim 1, wherein the subject experiences pruritus prior to the administration of maralixibat chloride. 9. The method of claim 1, wherein the subject is at least 1 year of age. 10. The method of claim 1, wherein maralixibat chloride is administered prior to ingestion of food. 11. The method of claim 1, wherein maralixibat chloride is administered orally. 12. A method for treating Alagille Syndrome (ALGS) in a pediatric subject in need of such treatment comprising administering to the subject ##STR00065## (maralixibat chloride), wherein maralixibat chloride is administered in an amount of about 400 .mu.g/kg/day. 13. A method for treating Alagille Syndrome (ALGS) in a pediatric subject in need of such treatment comprising administering to the subject ##STR00066## (maralixibat chloride), wherein maralixibat chloride is administered in an amount of about 800 .mu.g/kg/day.

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